【作者】 何晓燕；

【导师】 吴纯洁；

【作者基本信息】 成都中医药大学 ， 药剂学， 2010， 硕士

【摘要】 XE泡腾片系由柴胡、黄芩、葛根、金银花等中药加工制成的制剂,具有清热解毒,泻火利咽之功效。用于小儿外感高热,头痛,咽喉肿痛,鼻塞,流涕,咳嗽,大便干结,舌质红,舌苔薄白或黄,脉数或指纹浮紫等症。本课题以传统中医药理论为指导,运用现代制药技术,对该泡腾片进行了临床前药学部分的研究。根据临床用药的需要,结合处方给药途径,确定制成泡腾片。根据处方的功能主治及药物所含成分的理化性质,拟定了工艺路线,以挥发油收量为指标,筛选出挥发油的最佳提取工艺为：浸泡2小时,加8倍量水提取4小时。采用正交试验方法筛选出β-CD包合挥发油的最佳包合工艺。采用正交试验方法筛选出黄芩等药材的最佳水提工艺为：黄芩等药材加8倍量水提取2次,每次2小时。合并水提液,滤过,浓缩至相对密度1.30-1.35(60℃)。成型工艺,以泡腾片的崩解时限为指标,采用正交试验方法筛选出浸膏与酸碱的比例、酸碱的比例、稀释剂和崩解剂的用量,制成1000片。经三批中试试制,工艺稳定可行。在制剂质量标准研究中,重点对薄层色谱鉴别与含量测定开展了研究。实验对方中药味均进行了鉴别,其中柴胡、黄芩、葛根、金银花、大黄展开效果较好,故收入本品质量标准正文；采用HPLC法测定黄芩中黄芩苷的含量,并作了系统方法学研究。试验结果均符合要求,故列入标准正文。暂定样品每片含黄芩苷不得少于15.0mg。以加速试验和常温留样观察法考察样品的稳定性,初步稳定性试验表明三批样品性状、鉴别、检查及含量测定等均符合规定。以上试验表明：本品制备工艺合理可行,质量标准可控,成品质量基本稳定。更多还原

【Abstract】 XE Effervescent Tablets, prepared from the drugs of Bupleuri Radix, Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma, etc. possesses the functions of carambola detoxification, and swallow purging fire, and is indicated for the treatment of pediatric diseases, headache, sore throat and high nose, sore throat, cough, defecate, runny nose, tongue is red, dry coating thin white or yellow, purple or pulse etc. Under the guidance of Traditional Chinese Medicine theories, and with the help of the modern pharmaceutical technology, XE Effervescent Tablets was studied on pre-clinical pharmaceutical reasearch.Based on the functions and indications and the characteristics of the ingredients in the herbs,the optium extraction technology of essential oil is using 8-fold volume of water to erxtract 4 h; collect volatile oil, and the mixed oil was included by P-CD. According to the actions and indications as well as the physico-chemical properties of the ingredients included in the herbs, by means of the multiple guidelines grading method and the orthogonal test, the optimum extraction technology was determined as follows:Extract Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma, etc. with water for 2 times, using 8-fold volume of ethanol for 2 hour each time, combine the extract for use, filter, then concentrate to a thin extract with a relative density of 1.30～1.35 (60℃), Combine the above-mentioned thin extract, then arescent under reduced pressure and pulverize it to powder, Add the lactose, tartaric acid, pvpp,and PEG 6000, then prepare it to 1000 tablets.According to the guiding principles of Chinese medicine new drug research, the quality standard research was carried out. TLC was used to identify the 8 ingredients in prescription respectively, among which Bupleuri Radix, Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma,and Loniceae japonicar flos had comparatively better results, thus the methods were included into the normal test of quality standard. The contents of baicalin in Scutellariae Radix was determined using HPLC as indicators of internal quality control, and the systematic methodology were accomplished. All results complied with the specified standards concerned, thus the method was included into the normal test of quality standard. According to the experimental results of multi-batch samples, the total count of baicalin should not be lower than 15.0mg 1 tablet.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.更多还原